FDA Publishes List of Guidances Scheduled for 2016

The US Food and Drug Administration (FDA) published its guidance agenda for calendar year 2016 and identified the new and revised draft guidances that FDA's Center for Drug Evaluation and Research plans to publish during calendar year 2016. The list includes guidances on biosimilarity, chemistry, manufacturing and controls (CMC), manufacturing and quality, including on data integrity, and generics. Agenda items reflect draft and revised draft guidances under development as of January 22, 2016.

FDA said it plans to issue three guidances relating to biosimilarity:
• Considerations in Demonstrating Interchangeability With a Reference Product
• Labeling for Biosimilar Products
• Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity.

Among its procedural guidances, the FDA plans to issue several guidances relating to the the Drug Supply Chain Security Act (DSCSA), which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.